BELOIT, Wis.--(BUSINESS WIRE)--The Board of Managers of NorthStar Medical Technologies, LLC (“NorthStar” or the “Company”), a global innovator in the production and distribution of radioisotopes used for medical imaging, today announced the appointment of Stephen Merrick as President and Chief Executive Officer. Mr. Merrick has been with NorthStar since March 2016, initially in the role of Chief Operating Officer and later as President and Chief Operating Officer.
Mr. Merrick replaces outgoing Chairman and Chief Executive Officer George Messina, who was named Chairman Emeritus. Mr. Messina was simultaneously appointed President and Chief Executive Officer of NorthStar Nuclear Therapies LLC (“NNT”), a wholly-owned subsidiary of NorthStar focused on developing medical isotopes for therapeutic applications. Diane Hendricks, Chairperson of Hendricks Holding Company, Inc. has assumed the Chairperson role for both Companies’ Board of Managers.
“As founder, George has been the driving force from NorthStar’s inception through FDA approval of the RadioGenix® System to the initial commercial sale of domestically produced Mo-99. We thank George for his successful leadership in NorthStar’s effort to become the first U.S.-based producer of Mo-99,” said Diane Hendricks, Chairperson of the NorthStar Board of Managers. “George’s passion and dedication were critical to building NorthStar into a global leader in the development of novel technologies for the production of medical isotopes for medical imaging. We are excited that George is assuming the leadership of NNT as President and Chief Executive Officer. Targeted Alpha Therapy (“TAT”) isotopes, including Actinium-225, produced by NNT have been identified as potential options in the treatment of certain cancers and infectious diseases. NNT’s therapeutic isotopes will offer more patients the potential for improved outcomes that were previously constrained by inadequate TAT isotope supply. We are looking to George to achieve similar success leading NNT as he has done with NorthStar.”
“NorthStar is at a transformative point in its evolution from a development stage company to being the first domestic supplier of Mo-99, and we are excited that Steve has agreed to become NorthStar’s President and CEO,” continued Ms. Hendricks. “This Company is strongly positioned for rapid growth in the U.S. market, and there are attractive opportunities for NorthStar to grow outside the United States as well. Steve’s broad executive experience in the pharmaceutical industry at Bristol-Myers Squibb, Mallinckrodt and Baxter Healthcare, as well as his expertise in product development and driving domestic and global market demand are invaluable to NorthStar’s future success. The Board of Managers believes that this organizational realignment allows NorthStar to capitalize on both George and Steve’s strengths.”
Prior to joining NorthStar, Mr. Merrick served as Vice President, International Marketing for Baxter International’s Hospital Products business. Previously, he was Senior Vice President and President - International Commercial Operations for Mallinckrodt Pharmaceuticals and worked in management at Bristol-Myers Squibb for 17 years, holding a series of increasingly responsible positions around the world. Mr. Merrick began his career with Eli Lilly and Company.
About the RadioGenix® System
The
RadioGenix System is an innovative, high tech system that is approved
for processing non-uranium/non-highly enriched uranium molybdenum-99
(Mo-99) for the production of the important medical radioisotope,
technetium-99m (Tc-99m). Prior to availability of RadioGenix technology,
the U.S. supply chain for Mo-99 has been subject to frequent and
sometimes severe interruptions which negatively impact patient
healthcare. Approved by the U.S. Food and Drug Administration in
February 2018, the RadioGenix System is the first and only on-site,
automated isotope separation system of its kind for use with
non-uranium/non-highly enriched uranium based Mo-99.
Indication and Important Risk Information About the RadioGenix® System and Sodium Pertechnetate Tc 99m Injection USP
The RadioGenix® System is a technetium Tc-99m generator used to produce Sodium Pertechnetate Tc 99m Injection, USP. Sodium Pertechnetate Tc 99m Injection is a radioactive diagnostic agent and can be used in the preparation of FDA-approved diagnostic radiopharmaceuticals.
Sodium Pertechnetate Tc 99m Injection is also indicated in
- Adults for Salivary Gland Imaging and Nasolacrimal Drainage System Imaging (dacryoscintigraphy).
- Adults and pediatric patients for Thyroid Imaging and Vesicoureteral Imaging (direct isotopic cystography) for detection of vesicoureteral reflux.
IMPORTANT RISK INFORMATION
- Allergic reactions (skin rash, hives, or itching) including anaphylaxis have been reported following the administration of Sodium Pertechnetate Tc 99m Injection. Monitor all patients for hypersensitivity reactions.
- Radiation risks associated with the use of Sodium Pertechnetate Tc 99m Injection are greater in children than in adults and, in general, the younger the child, the greater the risk owing to greater absorbed radiation doses and longer life expectancy. These greater risks should be taken firmly into account in all benefit-risk assessments involving children. Long-term cumulative radiation exposure may be associated with an increased risk of cancer.
- Temporarily discontinue breastfeeding. A lactating woman should pump and discard breastmilk for 12 to 24 hours after Sodium Pertechnetate Tc 99m Injection administration.
- Sodium Pertechnetate Tc 99m Injection should be given to pregnant women only if the expected benefits to be gained clearly outweigh the potential hazards.
- Only use potassium molybdate Mo-99, processing reagents, saline and other supplies, including kits, provided by NorthStar Medical Radioisotopes. Do not administer Sodium Pertechnetate Tc 99m Injection after the 0.15 microCi of Mo-99/mCi of Tc-99m limit has been reached or when the 12 hour expiration time from elution is reached, whichever occurs earlier.
To report SUSPECTED ADVERSE REACTIONS, contact NorthStar Medical Radioisotopes, LLC at 1-844-438-6659; or FDA at 1-800-332-1088 or www.fda.gov/medwatch.
For Full RadioGenix® System Prescribing Information, click here or visit https://www.northstarnm.com/wp-content/uploads/2018/04/PI_Rev04_23mar2018.pdf.
About Medical Radioisotopes - Molybdenum-99 (Mo-99) and
Technetium-99m (Tc-99m)
Tc-99m is a radioisotope used in a
variety of diagnostic testing procedures. It is currently the most
widely used medical radioisotope in the United States, used in more than
10 million diagnostic procedures annually. Tc-99m-based
radiopharmaceuticals are used to diagnose and stage heart disease,
cancer, infection, inflammation and other conditions.
Tc-99m is derived from the radioisotope Mo-99. The United States uses about 50% of the world’s Mo-99/Tc-99m for medical purposes, but U.S. supply of Mo-99 has been completely reliant on foreign sources and subject to frequent and sometimes protracted interruptions which negatively impact patient healthcare. Other Mo-99 producers continue to use enriched uranium in their processing which poses significant environmental concerns. NorthStar’s technology uses stable isotopes of molybdenum to produce Mo-99 domestically without incurring the concerns related to the management of toxic waste associated with Mo-99 production from enriched uranium.
About NorthStar Medical Technologies, LLC (NorthStar)
NorthStar
Medical Radioisotopes is a global innovator in the production and
distribution of radioisotopes used for medical imaging. Founded in 2006
and based in Beloit, Wis., NorthStar Medical Technologies is the parent
organization of several wholly-owned subsidiaries, including NorthStar
Medical Radioisotopes, LLC. NorthStar Medical Radioisotopes is a nuclear
medicine technology company committed to providing the United States
with reliable and environmentally friendly radioisotope supply solutions
to meet the needs of patients and to advance clinical research. The
Company’s first product is the RadioGenix® System, an
innovative and flexible platform technology initially approved by the
U.S. Food and Drug Administration in February 2018 for the processing of
non-uranium/non-highly enriched uranium based molybdenum-99 (Mo-99), the
parent isotope of technetium-99m (Tc-99m), which is currently the most
widely used diagnostic radioisotope for medical purposes. NorthStar’s
proprietary and patented technologies include non-uranium based
molybdenum-99 domestic production methods, patented separation chemistry
systems, patented sterilization systems and a technology platform that
potentially allows expanded product offerings to provide solutions in
both the diagnostic and therapeutic markets. For more information,
visit: www.northstarnm.com
